Affimed N.V. announced two upcoming presentations on its lead innate cell engager (ICE®?) AFM13 at the American Society of Hematology (ASH) 2023 Annual Meeting. In the first presentation, Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center and principal investigator of the study, will present the updated results from the AFM13-104 phase 1/2 trial evaluating AFM13 in combination with cord blood-derived natural killer (cbNK) in patients with CD30-positive relapsed or refractory (r/r) Hodgkin and non-Hodgkin lymphomas in an oral presentation, on December 11, 2023 at 11:45 a.m. PST /2:45 p.m. EST. A total of 42 patients were enrolled in the study with 36 patients treated at the RP2D.

All patients were heavily pretreated and refractory to their most recent line of therapy with active progressive disease at the time of enrollment. As of the July 2023 cut-off date for data presented in the abstract, the treatment regimen achieved an objective response rate (ORR) of 94.4% with a complete response rate of 72.2% in the patients treated at the RP2D. In addition, the treatment regimen demonstrated a good safety and tolerability profile with no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) or graft versus host disease (GVHD) of any grade.

Across all dose levels as of the cutoff date, median event free survival (EFS) and overall survival (OS) were 8 months and not reached, respectively. A more in-depth analysis of the data and updated EFS/OS data using a later cut-off date will be presented during Dr. Nieto?s oral presentation. The second presentation will be a poster featuring the design of Affimed?s phase 2 LuminICE-203 clinical trial investigating AFM13 in combination with Artiva?s AlloNK® (also known as AB-101), an allogeneic, non-genetically modified NK cell therapy candidate.

The open-label, multi-center, multi-cohort study (NCT05883449) study is based on the unprecedented results achieved in the investigational AFM13-104 study and will evaluate the efficacy and safety of the combination in patients with r/r HL and certain r/r CD30+ PTCL subtypes. Affimed has recently received Fast-track designation for the AFM13/AB-101 combination. Details of AFM13 Oral Presentation and Abstract: Title: Innate Cell Engager (ICE®) AFM13 Combined with Preactivated and Expanded (P+E) Cord Blood (CB)-Derived Natural Killer (NK) Cells for Patients with Refractory CD30-Positive Lymphomas: Final Results Session: Cellular Immunotherapies: Early Phase and Investigational Therapies: Novel Approaches to Enhance Cellular Therapies and Immune Responses in Leukemias and Lymphomas Date & Time:Monday, December 11, 2023 at 11:45 a.m. PST Location: San Diego Convention Center, Room 6CF.

Details of LuminICE-203 Poster Presentation: Title: AFM13 in Combination with Allogeneic Natural Killer Cells (AB-101) in Relapsed or Refractory Hodgkin Lymphoma and CD30+ Peripheral T-Cell Lymphoma: A Phase 2 Study (LuminICE). Session: Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster III Session Date & Time:Monday, December 11, 2023 from 6:00 p.m. - 8:00 p.m. PST Location:San Diego Convention Center, Halls G-H. The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-sponsored phase 1/2 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The study is a dose-escalation trial of precomplexed NK cells, followed by an expansion phase, recruiting up to 40 patients with r/r CD30 positive lymphomas, treated with the RP2D of1×108 NK cells/kg) followed by three weekly doses of 200 mg AFM13 monotherapy.

Each treatment cycle consists of lymphodepleting chemotherapy with fludarabine (30 mg/m² per day) and cyclophosphamide (300 mg/m² per day) followed two days later by a single infusion of cytokine-preactivated and expanded cord blood-derived NK cells that are pre-complexed with AFM13. Three weekly infusions of AFM13 (200 mg) monotherapy are subsequently administered and responses are assessed by the investigator on day 28 by FDG-PET. AFM13 is a first-in-class innate cell engager (ICE®) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors.

AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is a tetravalent bispecific innate cell engager designed to act as a bridge between the innate immune cells and the tumor creating the necessary proximity for the innate immune cells to specifically destroy the tumor cells.